FDA Expands Diabetes Drug Indication

The FDA has approved Invokana (canagliflozin) for the reduction of risk of end-stage kidney disease (ESKD) and cardiovascular events in adults with type 2 diabetes and diabetic kidney disease (DKD).

In 2013, Invokana was the first SGLT2 inhibitor to be approved by the FDA in the United States for the treatment of patients with type 2 diabetes.

The new indication makes the drug the first diabetes drug indicated for the reduction of DID risk in patients with type 2 diabetes.

The new indication is based upon redults from a phase III trial of patients with type 2 diabetes and DKD that was stopped early because the drug was shown to meet prespecified criteria for efficacy. Invokana 100 mg was associated with a 30% reduction in the primary composite endpoint (end-stage kidney disease, doubling of serum creatinine and renal or cardiovascular-related mortality).

Invokana carries warnings for increased risk of lower-limb amputations, dehydration, and vaginal and penile yeast infections. The most common side effects include yeast infections and changes in urination.

—Michael Potts

Reference:

U.S. FDA approves Invokana® (canagliflozin) to treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and DKD [press release]. Raritan, New Jersey. September 30, 2019. https://www.janssen.com/us-fda-approves-invokana-canagliflozin-treat-diabetic-kidney-disease-dkd-and-reduce-risk.